Coronavirus

New COVID-19 antibody infusion approved by FDA. They’re using it at Bradenton hospital

Blake Medical Center in Bradenton is one of four HCA West Florida hospitals now offering Bamlanivimab antibody infusions to non-hospitalized patients who have tested positive for COVID-19 and have other high-risk factors.

The first patient received the treatment on Wednesday at St. Petersburg General Hospital. The patient, identified only as Harry, was visiting from Massachusetts when he developed symptoms of early onset COVID-19. He was evaluated as an excellent candidate for the new therapy based on his medical history.

Other HCA hospitals offering the treatment include Brandon Regional Hospital and Medical Center of Trinity in Pasco County.

The U.S. Food & Drug Administration has granted emergency authorized use of Bamlanivimab for the treatment of COVID-19 patients experiencing mild to moderate symptoms who are high risk to develop severe COVID-19. All four hospitals will provide the outpatient IV treatment for adults. Brandon Regional Hospital will also provide the treatment for adolescents age 12 and older, according to an HCA press release.

High-risk conditions that may be eligible for this treatment include obesity, chronic kidney disease, COPD, diabetes, immunosuppressive disease,and heart disease.

For children over the age of 12, sickle cell disease, neurodevelopmental disorders and asthma are also among several additional considerations for eligibility.

Blake Medical Center now offers Monoclonal Antibody Therapy IV treatment for the early onset of COVID-19. The outpatient IV treatment is approved by the FDA for patients at high risk.
Blake Medical Center now offers Monoclonal Antibody Therapy IV treatment for the early onset of COVID-19. The outpatient IV treatment is approved by the FDA for patients at high risk. Bradenton Herald file photo

The treatment has to be given early for it to work, so hospital officials are pushing the message that people who feel ill should get tested for the SARS-CoV-2 virus and, if positive, call their physician or report to the emergency room as soon as possible.

That requires a certain degree of vigilance, said Madeline Camejo, chief pharmacy officer at Baptist Health of South Florida.

“People think they have the cold or they have sniffles, then three days have gone by and they’re getting a little sicker, then they have fever and chills,” Camejo said. “Some either break it at that point, or they start getting really sick and end up in our ER.”

But by the time many people get to the ER, Camejo said, “it may be too late to give you this.”

The monoclonal antibody treatment, which was made famous by President Donald Trump, is made by two companies — Regeneron and Eli Lilly — and are being allocated to area hospitals by the Florida Department of Health, according to hospital officials. State health officials are regulating the supply because the medicines are under an emergency authorization by the federal government.

“We’re committed to providing our patients, caregivers, and the communities we serve with the latest treatments in the fight against COVID-19 and are excited to bring this option to our four different geographic areas along Florida’s west coast,” Dr. Larry Feinman, chief medical officer for HCA Healthcare West Florida, said in the press release.

“The four locations will support all of our local hospitals in working closely with physicians and other providers across the communities we serve to provide treatment to patients who may benefit, per FDA guidelines,” Feinman said.

The medication supply is limited and based on availability. Patients will need a physician referral and meet FDA criteria prior to scheduling.

St. Petersburg General Hospital successfully performed its first Monoclonal Antibody Therapy IV treatment for the early onset of COVID-19. Shown above are nurse Kandice Williams (left) and Dr. Vinson Huynh with patient Harry (center) on Dec. 9 The outpatient IV treatment is approved by the FDA for patients at high risk. The treatment is available at Blake Medical Center.
St. Petersburg General Hospital successfully performed its first Monoclonal Antibody Therapy IV treatment for the early onset of COVID-19. Shown above are nurse Kandice Williams (left) and Dr. Vinson Huynh with patient Harry (center) on Dec. 9 The outpatient IV treatment is approved by the FDA for patients at high risk. The treatment is available at Blake Medical Center. provided photo

The treatment is a one-time intravenous infusion of man-made, synthetic antibodies designed to target the spike protein on the surface of the COVID-19 virus over the course of one hour followed by an hour of monitoring.

That can help the body gear up its immune system to slow viral growth, but physicians say this is only beneficial in the early stages of the infection, and can actually be counterproductive in the later stage, when patients need to be hospitalized. At that point, their immune systems actually need help calming down so they can stop attacking their own organs, particularly their lungs.

“If you’re in a hospital, on a ventilator or in an [intensive care unit], it’s not shown to be helpful,” said Dr. Robert Goldszer, chief medical officer at Mount Sinai Medical Center in Miami Beach. “The key message that I give to people about this is, if you don’t feel well, be in touch with your doctor ... this can really turn things around, but it has to be given early.”

In the Tampa Bay region, scheduling for patients who meet the criteria can be made by calling Blake Medical Center at 941-798-6150, Brandon Regional Hospital at 813-916-1581 or 813-460-3187, Medical Center of Trinity at 727-834-4917 and St. Petersburg General Hospital at 727-341-4909.

Bamlanivimab is not authorized for use for patients who are hospitalized due to COVID-19, or who require oxygen therapy due to COVID-19 or another underlying medical condition

For more information on monoclonal antibody treatment for COVID-19, visit the Coronavirus Research Hub at HCA Healthcare.com.

The Miami Herald contributed to this story.

This story was originally published December 12, 2020 at 5:00 AM.

James A. Jones Jr.
Bradenton Herald
James A. Jones Jr. covers business news, tourism and transportation for the Bradenton Herald.
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